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School Based Prevention for Childhood Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044678
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Armando Pina, Arizona State University

Brief Summary:
This study was designed to conceptualize a school-based prevention program or childhood anxiety.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: REACH for Success Behavioral: Self-Study Not Applicable

Detailed Description:
This is a project corresponding to a career development grant. The main goal of the proposed research was to identify potential barriers to implementing a school-based anxiety preventive intervention, identify strategies to overcome these barriers, and use this information to test a school-based indicated intervention for child anxiety.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Masked or blinded to hypotheses
Primary Purpose: Prevention
Official Title: School Based Prevention for Childhood Anxiety
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : January 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Experimental: REACH for Success
Experimental: Exposure-based, cognitive and behavioral, social skills training intervention 6-weeks - 6 session -20-30 min each
Behavioral: REACH for Success
Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)

Active Comparator: Active Comparator: Self-study
Active Comparator: Books "What to do when you are scared and worried?How to do homework without throwing-up? How to get organized without losing it?" Reading at home
Behavioral: Self-Study
Books for youth about anxiety management




Primary Outcome Measures :
  1. Change in child anxiety symptoms (clinical) [ Time Frame: Change from baseline to 12-month follow-up ]
    Child anxiety symptoms based on the Multidimensional Anxiety Scale for Children

  2. Change in child anxiety levels (typical) [ Time Frame: Change from baseline to 12-month follow-up ]
    Child anxiety based on the Spence Child Anxiety Scale


Secondary Outcome Measures :
  1. Changes in child negative cognition [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire

  2. Changes in child negative cognition [ Time Frame: Change from baseline to 12-month follow-up ]
    Children's Negative Cognitive Errors on the Children's Negative Cognitive Errors Questionnaire

  3. Changes in emotion understanding and expression [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children

  4. Changes in emotion understanding and expression [ Time Frame: Change from baseline to 12-month follow-up) ]
    Children's Emotion Expressivity based on the Emotion Expressivity Scale for Children

  5. Changes in self efficacy [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations

  6. Changes in self efficacy [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child self efficacy based on the Children's Self-Efficacy Questionnaire for Handling School Situations

  7. Changes in child social skills [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child social skills based on the Social Skills Improvement Rating System

  8. Changes in child social skills [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child social skills based on the Social Skills Improvement Rating System

  9. Changes in somatic arousal [ Time Frame: Change from baseline to immediate posttest (at 6-weeks) ]
    Child somatic arousal based on the Physiological Hyperarousal Scale for Children

  10. Changes in somatic arousal [ Time Frame: Change from baseline to 12-month follow-up) ]
    Child somatic arousal based on the Physiological Hyperarousal Scale for Children



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

Borderline child anxiety levels based on the Spence Child Anxiety Scale

Exclusion:

Externalizing problems (based on teacher nominations) more severe than Spence Child Anxiety Scale borderline levels

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Responsible Party: Armando Pina, Associate Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03044678    
Other Study ID Numbers: MH086687
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders